Recall archive
444 recalls · page 2 of 19
Reported Dec 10, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand — There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CareLink Clinic, REF: MMT-7350
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based…
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological…
FDA (openFDA device enforcement)
Reported Nov 26, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Product · Product details — The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting…
FDA (openFDA device enforcement)
Reported Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand — The catheters may not retain their shape.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Due to out of the box wobble of the driver.
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details — In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details · Reason for recall — A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2025
O-arm O2 Imaging System. Mobile X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
Matched: Brand — A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Azure S DR MRI SureScan, Product number W3DR01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand — Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential…
FDA (openFDA device enforcement)
Reported Jun 11, 2025Updated Aug 26, 2026
Medtronic recalls Newport™ Newport™ HT70 and HT70 Plus ventilators and certain related service parts due to Device & Drug Safety - Potential Defect
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Medtronic
Matched: Brand · Product — Device & Drug Safety - Potential Defect
FDA (recalls & safety alerts)
Reported May 7, 2025
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An…
FDA (openFDA device enforcement)
Reported Apr 30, 2025
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the…
FDA (openFDA device enforcement)
Reported Apr 30, 2025
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead…
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Product · Product details · Reason for recall — Medline medical procedure kits, containing Medtronic Aortic Root Cannula
10 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative…
FDA (openFDA device enforcement)
Reported Apr 9, 2025
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand — Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use -…
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Paradigm REF: MMT-712 and MMT-715
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Reason for recall — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Micro Therapeutics, Inc.
Matched: Product · Product details — Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
FDA (openFDA device enforcement)
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